Data / Medical devices / China / He Chuang Plastic & Rubber Co., Ltd
He Chuang Plastic & Rubber Co., Ltd: FDA-registered device maker in Zibo Shandong, China, 3 510(k) clearances
He Chuang Plastic & Rubber Co., Ltd is registered with the FDA (registration 3015335977) in Zibo Shandong, China. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015335977
- Address
- Lot 2, No. 21 Qingtian Road Qilu Chemical Industrial Park, Zibo Shandong, China, 255414
- Owner or operator
- He Chuang Plastic & Rubber Co., Ltd (10060105)
- Roles
- Exporter to the US, Manufacturer, Specification developer
- First device listed
- March 29, 2019
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Exporter to the US | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 4, 2022 | K222815 | Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl | LZA | Substantially Equivalent | Zibo Lanhua Medical Packaging Material Co., Ltd. | accessdata.fda.gov |
| March 18, 2022 | K220228 | Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs | LZA | Substantially Equivalent | Shandong Blue Sail Health Technology Co., Ltd. | accessdata.fda.gov |
| March 22, 2019 | K182554 | Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs | LZA | Substantially Equivalent | He Chuang Plastic & Rubber Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Polymer Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
Updated December 4, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.